UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033725
Receipt number R000038457
Scientific Title Therapeutic effect on disodium pamidronate administration to diffuse sclerosing mandible osteomyelitis
Date of disclosure of the study information 2020/10/01
Last modified on 2022/08/15 12:14:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Therapeutic effect on disodium pamidronate administration to diffuse sclerosing mandible osteomyelitis

Acronym

On the effect of disodium pamidronate on diffuse curable mandibular osteomyelitis

Scientific Title

Therapeutic effect on disodium pamidronate administration to diffuse sclerosing mandible osteomyelitis

Scientific Title:Acronym

On the effect of disodium pamidronate on diffuse curable mandibular osteomyelitis

Region

Japan


Condition

Condition

diffuse sclerosing osteomyelitis

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Diffuse sclerosing osteomyelitis (DSO) is recognized as refractory osteomyelitis. In recent years, it has been reported that disodium pamidronate, a bisphosphonate preparation, has been effective, and also in our department, administration of disodium pamidronate to patients who have long-term illness period in DSO consider.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dissolve pamidronate disodium in 500ml of raw diet for patients with diffuse osteomyelitis and take IV infusion over 4 hours. The number of doses is only once, but when symptoms such as pain are observed, re-administration is performed at intervals of 3 to 6 months.Comparison of changes in jaw bone due to clinical symptoms and image findings before and after administration of disodium pamidronate, and evaluate the improvement effect of diamid pamidronate on DSO

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent dental oral surgery at Osaka Medical University Hospital and underwent treatment with diamantane pamidronate for DSO

Key exclusion criteria

Patients who did not obtain consent to this study

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Ueno
Middle name
Last name Takaaki

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Oral and Maxillofacial Surgery

Zip code

5698686

Address

2-7 Daigakumachi Takatsukishi, Osaka, Japan

TEL

0726831221

Email

n4160@osaka-med.ac.jp


Public contact

Name of contact person

1st name Nakajima
Middle name
Last name Yoichiro

Organization

Osaka Medical and Pharmaceutical University

Division name

Department of Oral and Maxillofacial Surgery

Zip code

5698686

Address

2-7 Daigakumachi Takatsukishi, Osaka, Japan

TEL

0726831221

Homepage URL


Email

n4160@ompu.ac.jp


Sponsor or person

Institute

Department of Oral and Maxillofacial Surgery, Osaka Medical and Pharmaceutical University

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical and Pharmaceutical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Medical and Pharmaceutical University

Address

2-7 Daigakumachi Takatsukishi, Osaka, Japan

Tel

0726831221

Email

n4160@ompu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

大阪医科薬科大学病院


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

5

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 10 Month 01 Day

Date of IRB

2018 Year 09 Month 10 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Effective judgment based on image findings, clinical findings, blood tests from the time of pamidronate administration completion.


Management information

Registered date

2018 Year 08 Month 12 Day

Last modified on

2022 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038457


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name